Orphan designation: chimeric human-murine IgG1 kappa monoclonal antibody against TNF alfa Treatment of sarcoidosis, 25/07/2023 Positive

Key facts

Metadata

Provider: 

European Medicines Agency

URL: 

https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-23-2809

Retrieved on: 

星期日, 二月 4, 2024

Information

Tags: 

TNF, Sarcoidosis, Immunoglobulin G, COMP, IRIS, EMA, European Commission, Patient, Committee, Pharmaceutical industry

Geotags: 

RARE, EU

摘要

Key Points: 

• Key facts
  - Active substance
  - chimeric human-murine IgG1 kappa monoclonal antibody against TNF alfa
  - Intended use
  - Treatment of sarcoidosis
  - Orphan designation status
  - Positive
  - EU designation number
  - EU/3/23/2809
  - Date of designation
  - Sponsor
  FGK Representative Service GmbH
  Patients' organisations
  For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
  European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
• EU register of orphan medicines
  The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
  EMA list of opinions on orphan medicinal product designation
  EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

Copyright: 

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